Xibrom performs well at Phase III

Article

Xibrom (bromfenac sodium ophthalmic solution) 0.09% (ISTA Pharmaceuticals, Inc.) achieved the primary endpoint of its Phase III trial: absence of ocular inflammation 15 days postoperatively.

Xibrom (bromfenac sodium ophthalmic solution) 0.09% (ISTA Pharmaceuticals, Inc.) has achieved the primary endpoint of its Phase III trial: absence of ocular inflammation 15 days postoperatively.

In two multicentre, randomized, double-masked trials, 282 patients undergoing cataract surgery were dosed with either Xibrom or placebo once daily for one day before and 14 days following surgery.

In addition to achieving its primary endpoint, Xibrom also met the secondary endpoint of the trial: eradication of ocular pain at one day postoperatively. These results were cumulative: one of the trial arms showed statistical significance in achievement of both primary and secondary endpoints, while the second arm did not achieve statistical significance in either. In this second arm, there was a higher percentage of discontinuation due to lack of efficacy, and a greater reported response to placebo. There were no significant ocular or systemic adverse events in either trial arm, and an overall trend of decrease in photophobia was witnessed.

ISTA now plans to perform a further Phase III trial, which the company expects to conclude next year.

Newsletter

Join ophthalmologists across Europe—sign up for exclusive updates and innovations in surgical techniques and clinical care.

Recent Videos
Christine Curcio, PhD, of the University of Alabama at Birmingham Heersink School of Medicine, shares histology update and revised nomenclature for OCT with Sheryl Stevenson of the Eye Care Network and Ophthalmology Times
SriniVas R. Sadda, MD, FARVO, shares key points from his retina presentation at the International SPECTRALIS Symposium
Robert Sergott, MD, describes fluorescence lifetime imaging ophthalmoscopy (FLIO) and the International SPECTRALIS Symposium – And Beyond (ISS) in Heidelberg, Germany.
Rayaz Malik, MBChB, PhD, a professor of medicine at Weill Cornell Medicine - Qatar, spoke with Ophthalmology Times Europe about his presentation. It's titled "An eye on neurodegenerative diseases: Challenging the dogma" at the International SPECTRALIS Sympsoium. In conversation with Hattie Hayes, Ophthalmology Times Europe
Anat Loewenstein, MD, describes her presentation on remote imaging for age-related macular degeneration and geographic atrophy at the International SPECTRALIS Symposium, in conversation with Hattie Hayes of Ophthalmology Times Europe
Tyson Brunstetter, OD, PhD, a US Navy Aerospace Optometrist at the NASA Johnson Space Center in Houston, Texas, shares key takeaways from his keynote at the International SPECTRALIS Symposium (ISS)
Rayaz Malik, MBChB, PhD, shares his presentation, titled An eye on neurodegenerative diseases: Challenging the dogma, at this year's International SPECTRALIS Symposium
At the Retina World Congress, Siegfried Priglinger, MD, speaks about ensuring the best outcomes for preschool-aged patients
At the 2025 ASCRS meeting, Robert Ang, MD said small aperture IOLs can benefit all patients, especially those with complex corneas or who have undergone previous corneal refractive surgery
Viha Vig, MBChB graduate student at the University of Auckland, New Zealand, discusses her poster presentation on the relationship between mitochondiral disease, Alzheimer disease, and other types of dementia.
© 2025 MJH Life Sciences

All rights reserved.